Skip to content

Surgisis Rvp Recto-Vaginal Fistula Plug

by Cook Biotech, Inc.

510(k) K062729

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

12 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK062729 Date10 Oct 2006ClearedStatusActive

Recalls

12 recalls · 12 ongoing · FDA

  • 12 recalls, same reason

    • Ongoing Z-3261-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3260-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3257-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3252-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3256-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3255-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3251-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3259-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3254-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3258-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3250-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3253-2024 FDA Class II initiated 7 Aug 2024

    Products expire prior to the expiration date printed on the product labeling

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FTM
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Cook Biotech, Inc.

See all devices from Cook Biotech, Inc. →